SAURASHTRA UNIVERSITY RAJKOT · 2020. 6. 15. · Medicinal and scientific research skills,...

SAURASHTRA UNIVERSITY

RAJKOT (ACCREDITED GRADE “A” BY NAAC)

FACULTY OF PHARMACY Syllabus for

M. Pharm. (PHARMACOLOGY) Choice Based Credit System

With Effect From: 2017-18

1

PROGRAM OUTCOMES

POs OF M. PHARM (Pharmacology)

Students of all post undergraduate pharmacy degree programs at the time of graduation will

be able to learn:

PO 1: Research and development

The students will be able to generate ideas for research, analyse them, execute them and

publish the findings.

PO 2: Domain knowledge:

Students will be able to acquire knowledge and comprehension of the core and

specialization subjects of the respective pharmacy specialization.

PO 3: Communication skills:

Students will be able to learn communication by giving seminars, journal club and other

organizational activities. They will be able to comprehend and write effective reports, make

effective presentations and documentation.

PO 4: Planning skills:

Students will be able to demonstrate effective planning abilities including time

management, resource management, and organizational skills. They will be able to develop

and implement plans and organize work to meet deadlines.

PO 5: Problem analysis:

Students will be able to develop, critical thinking and analytical skills while solving

problems and making decisions in dissertation research.

PO 6: Usage of contemporary research tools and techniques:

Students will be able to learn, select, and apply appropriate current methods and procedures

in modern pharmaceutical research with an understanding of the limitations.

PO 7: Social responsibilities:

Students will be able to understand, analyze and communicate the value of their

professional roles in society (e.g. as health care professionals, promoters of health,

educators, managers, employers, employees).

PO 8: Continuous learning:

They will be able to recognize the need for continuous up gradation of their knowledge and

skills

2

PROGRAM SPECIFIC OUTCOMES

PSOs OF M. PHARM (Pharmacology)

Students of all post undergraduate pharmacy degree programs at the time of graduation will be

able to

POS1: Students will learn medical writing and ethics, drug marketing and patient

counselling skills

POS2: Students will learn various skills such as therapeutics and counselling skills,

Medicinal and scientific research skills, Communication skills and Interpersonal

skills

POS3: Students will learn the history of pharmacology, development of pharmacology in

India and global scenario.

POS4: Students will learn the concept of adverse drug reactions and drug toxicity so that

it can be minimized.

POS5: Students will learn commonly used instruments in experimental pharmacology by

handling them. They will learn standard operating procedures in handling

glassware’s and equipment’s required for pharmacology practical.

POS6: Students will learn the concept of rational drug treatment during pregnancy and

lactation, paediatric patients & in geriatric patients.

POS7: Students will learn the process of new drug discovery and development of drug,

and understand the basics of pharmacokinetic and pharmacodynamics.

POS8: Students will learn the pharmacotherapy and pharmacological features of common

and important drugs used in various diseases/disorders by understanding the

classification, mechanism of action, pharmacological action, pharmacokinetic,

therapeutic uses and contraindications of drug acting on various systems of the

body.

POS9: Students will learn regulatory guidelines such as CPCSEA, ICMR, CDSCO and

OECD guidelines.

POS10: Students will learn various methods to minimise drug-drug interaction and

prescription errors by doing its analysis. They will be able to learn the mechanism

of adverse drug reactions and pharmacovigilance.

POS11: Students will learn the clinical aspects of drug development and the hospital

pharmacy management.

POS12: Students will learn research and development by doing dissertation in

pharmacology

POS13: Students will learn scientific writing skills and follow ethics in writing. They will

develop critical thinking in scientific research.

3

DEPARTMENT OF PHARMACEUTICAL SCIENCES

Course Structure and Scheme of Examination

SEMESTER I

Subje

ct

Code

Title of the

Course

Cours

e

Credi

t

No. of

Hrs.

per wee

k

Weightage for

internal examinati

on

Weightage for end

semester examinati

on

Total

Mark

s

Duration of

semeste

r end exam in

Hrs.

MPL

101T

Modern Pharmaceutical

Analytical Techniques

4 4 25 75 100 3

MPL

102T

Advanced Pharmacology-I

4 4 25 75 100 3

MPL

103T

Pharmacological and Toxicological

Screening Methods-I

4 4 25 75 100 3

MPL

104T

Cellular and Molecular

Pharmacology 4 4 25 75 100 3

MPL

105P

Pharmacology Practical I

6 12 50 100 150 6

- Seminar/Assignm

ent 4 07 - 100 100 -

Total 26 35 650

4

SEMESTER II

Subject

Code

Title of the

Course

Course

Cred

it

No.

of

Hrs.

per wee

k

Weightag

e for internal

examinati

on

Weightag

e for end semester

examinati

on

Total Mar

ks

Durati

on of semest

er end

exam

in Hrs.

MPL

201T

Advanced Pharmacology II

4 4 25 75 100 3

MPL

202T

Pharmacological and

Toxicological Screening Methods-II

4 4 25 75 100 3

MPL

203T

Principles of Drug Discovery

4 4 25 75 100 3

MPL

204T

Experimental Pharmacology

practical- II 4 4 25 75 100 3

MPL

205P

Pharmacology Practical II

6 12 50 100 150 6

- Seminar/Assign

ment 4 07 - 100 100 -

Total 26 35 650

5

SEMESTER III

Subject

Code

Title of the

Course

Cours

e Credi

t

No.

of

Hrs. per

wee

k

Weightage

for internal

examinati

on

Weightage

for end semester

examinati

on

Total Mark

s

Duratio

n of

semester end

exam in

Hrs.

MRM

301T

Research Methodolo

gy and Biostatistic

s*

4 4 25 75 100 3 Hrs.

- Journal

club 1 1 25 - 25 -

-

Discussion /

Presentation (Proposal Presentatio

n)

2 2 50 - 50 -

- Research

Work 14 28 - 350 350 1 Hr.

Total 21 35 525

SEMESTER IV

Subject

Code

Title of the

Course

Cours

e Credi

t

No.

of

Hrs. per

wee

k

Weightage

for internal

examinati

on

Weightage

for end semester

examinati

on

Total Mark

s

Duratio

n of

semester end

exam in

Hrs.

- Journal club

01 01 25 - 25 -

-

Discussion /

Presentation (Proposal Presentatio

n)

03

03 75 - 75 -

- Research work and Colloquiu

m

16

31 - 400 400 1 Hr

Total 20 35 500

6

M.PHARM PHARMACOLOGY SEMESTER I

Modern Pharmaceutical Analytical Techniques (MPL 101T)

Theory: 4 Hrs. /Week Scope

This subject deals with various advanced analytical instrumental techniques for

identification, characterization and quantification of drugs. Instruments dealt are NMR,

Mass spectrometer, IR, HPLC, GC etc.

Objectives

After completion of course student is able to know about,

• Chemicals and Excipients

• The analysis of various drugs in single and combination dosage forms

• Theoretical and practical skills of the instruments

Course Outcomes

CO.1: The subject will teach graduates advanced analytical techniques like NMR, Mass

spectrometer, IR, HPLC, HPTLC etc. which can help them in their professional

carrier.

CO.2: This will learn student’s theoretical practical skills of the instruments and even the

qualitative and quantitative parameters of the drug.

Course content Unit 1 10 Hrs

a) UV-Visible spectroscopy: Introduction, Theory, Laws, Instrumentation associated

with UV-Visible spectroscopy, Choice of solvents and solvent effect and Applications

of UV-Visible spectroscopy.

b) IR spectroscopy: Theory, Modes of Molecular vibrations, Sample handling,

Instrumentation of Dispersive and Fourier – Transform IR Spectrometer, Factors

affecting vibrational frequencies and Applications of IR spectroscopy

c) Spectroflourimetry: Theory of Fluorescence, Factors affecting fluorescence,

Quenchers, Instrumentation and Applications of fluorescence spectrophotometer.

d) Flame emission spectroscopy and Atomic absorption spectroscopy: Principle,

Instrumentation, Interferences and Applications.

Unit 2 10 Hrs

NMR spectroscopy: Quantum numbers and their role in NMR, Principle, Instrumentation,

Solvent requirement in NMR, Relaxation process, NMR signals in various compounds,

Chemical shift, Factors influencing chemical shift, Spin-Spin coupling, Coupling constant,

Nuclear magnetic double resonance, Brief outline of principles of FT-NMR and 13C NMR.

Applications of NMR spectroscopy.

Unit 3 10 Hrs

Mass Spectroscopy: Principle, Theory, Instrumentation of Mass Spectroscopy, Different

types of ionization like electron impact, chemical, field, FAB and MALDI, APCI, ESI,

7

APPI Analysers of Quadrupole and Time of Flight, Mass fragmentation and its rules, Meta

stable ions, Isotopic peaks and Applications of Mass spectroscopy.

Unit 4 10 Hrs

Chromatography: Principle, apparatus, instrumentation, chromatographic parameters,

factors affecting resolution, isolation of drug from excipients, data interpretation and

applications of the following:

a) Thin Layer chromatography

b) High Performance Thin Layer Chromatography

c) Ion exchange chromatography

d) Column chromatography

e) Gas chromatography

f) High Performance Liquid chromatography

g) Ultra High Performance Liquid chromatography

h) Affinity chromatography

i) Gel Chromatography

Unit 5 10 Hrs

Electrophoresis: Principle, Instrumentation, working conditions, factors affecting

separation and applications of the following:

a) Paper electrophoresis

b) Gel electrophoresis

c) Capillary electrophoresis

d) Zone electrophoresis

e) Moving boundary electrophoresis

f) Iso electric focusing

X ray Crystallography: Production of X rays, Different X ray methods, Bragg‘s law,

Rotating crystal technique, X ray powder technique, Types of crystals and applications of

X-ray diffraction.

Unit 6 10 Hrs

Potentiometry: Principle, working, Ion selective Electrodes and Application of

potentiometry.

Thermal Techniques: Principle, thermal transitions and Instrumentation (Heat flux and

power-compensation and designs), Modulated DSC, Hyper DSC, experimental parameters

(sample preparation, experimental conditions, calibration, heating and cooling rates,

resolution, source of errors) and their influence, advantage and disadvantages,

pharmaceutical applications.

Differential Thermal Analysis (DTA): Principle, instrumentation and advantage and

disadvantages, pharmaceutical applications, derivative differential thermal analysis

(DDTA).

TGA: Principle, instrumentation, factors affecting results, advantage and disadvantages,

pharmaceutical applications.

8

REFERENCES

1. Spectrometric Identification of Organic compounds - Robert M Silverstein, 6th

edition, John Wiley & Sons, 2004.

2. Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler, Timothy A.

Nieman, 5th edition, Eastern press, Bangalore, 1998.

3. Instrumental methods of analysis – Willards, 7th edition, CBS publishers.

4. Practical Pharmaceutical Chemistry – Beckett and Stenlake, Vol II, 4th edition, CBS

Publishers, New Delhi, 1997.

5. Organic Spectroscopy - William Kemp, 3rd edition, ELBS, 1991.

6. Quantitative Analysis of Drugs in Pharmaceutical formulation - P D Sethi, 3rd

Edition, CBS Publishers, New Delhi, 1997.

7. Pharmaceutical Analysis - Modern Methods – Part B - J W Munson, Vol 11, Marcel.

Dekker Series

8. Spectroscopy of Organic Compounds, 2nd edn., P.S/Kalsi, Wiley estern Ltd., Delhi.

9. Textbook of Pharmaceutical Analysis, K A. Connors, 3rd Edition, John Wiley &

Sons, 1982.

9


Advanced Pharmacology – I (MPL 102T)


The subject is designed to strengthen the basic knowledge in the field of pharmacology and

to impart recent advances in the drugs used for the treatment of various diseases. In

addition, this subject helps the students to understand the concepts of drug action and

mechanisms involved.

Objectives

Upon completion of the course the student shall be able to:

• Discuss the pathophysiology and pharmacotherapy of certain diseases

• Explain the mechanism of drug actions at cellular and molecular level

• Understand the adverse effects, contraindications and clinical uses of drugs used in

treatment of diseases

Course Outcomes

CO.1: It strengthens the knowledge of Pharmacology, Pathophysiology and

Pharmacotherapeutics.

CO.2: It makes students to understand the mechanism of the drug at molecular level,

adverse drug effect, clinical use, Contraindications, and dosage of the drug

Course content Unit 1. 12 Hrs.

General Pharmacology

a) Pharmacokinetics: The dynamics of drug absorption, distribution, biotransformation

and elimination. Concepts of linear and non-linear compartment models. Significance

of Protein binding.

b) Pharmacodynamics: Mechanism of drug action and the relationship between drug

concentration and effect. Receptors, structural and functional families of receptors,

quantitation of drug receptors interaction and elicited effects.

Unit 2. 12 Hrs.

Neurotransmission

a) General aspects and steps involved in neurotransmission.

b) Neurohumoral transmission in autonomic nervous system (Detailed study about

neurotransmitters- Adrenaline and Acetyl choline).

c) Neurohumoral transmission in central nervous system (Detailed study about

neurotransmitters- histamine, serotonin, dopamine, GABA, glutamate and glycine].

d) Non adrenergic non cholinergic transmission (NANC). Co- transmission

10

Systemic Pharmacology

a) A detailed study on pathophysiology of diseases, mechanism of action, pharmacology

and toxicology of existing as well as novel drugs used in the following systems

b) Autonomic Pharmacology

c) Parasympathomimetics and lytics, sympathomimetics and lytics, agents affecting

neuromuscular junction

Unit 3. 12 Hrs.

• Central nervous system Pharmacology

• General and local anesthetics

• Sedatives and hypnotics, drugs used to treat anxiety.

• Depression, psychosis, mania, epilepsy, neurodegenerative diseases.

• Narcotic and non-narcotic analgesics.

Unit 4. 12 Hrs.

• Cardiovascular Pharmacology

• Diuretics, antihypertensives, antiischemics, anti- arrhythmics, drugs for heart failure

and hyperlipidemia.

• Hematinics, coagulants , anticoagulants, fibrinolytics and anti- platelet drugs

Unit 5. 12 Hrs.

• Autocoid Pharmacology

• The physiological and pathological role of Histamine, Serotonin, Kinins

Prostaglandins Opioid autocoids.

• Pharmacology of antihistamines, 5HT antagonists.

REFEERENCES

1. The Pharmacological Basis of Therapeutics, Goodman and Gillman‘s

2. Principles of Pharmacology. The Pathophysiologic basis of drug Therapy by David

E Golan, Armen H, Tashjian Jr, Ehrin J,Armstrong, April W, Armstrong,

Wolters, Kluwer-Lippincott Williams & Wilkins Publishers.

3. Basic and Clinical Pharmacology by B.G Katzung

4. Hand book of Clinical Pharmacokinetics by Gibaldi and Prescott.

5. Applied biopharmaceutics and Pharmacokinetics by Leon Shargel and Andrew

B.C.Yu.

6. Graham Smith. Oxford textbook of Clinical Pharmacology.

7. Avery Drug Treatment

8. Dipiro Pharmacology, Pathophysiological approach.

9. Green Pathophysiology for Pharmacists.

10. Robbins & Cortan Pathologic Basis of Disease, 9th Ed. (Robbins Pathology)

11

11. A Complete Textbook of Medical Pharmacology by Dr. S.K Srivastava published

by APC Avichal Publishing Company

12. KD.Tripathi. Essentials of Medical Pharmacology.

13. Modern Pharmacology with Clinical Applications, Craig Charles R. & Stitzel

Robert E., Lippincott Publishers.

14. Clinical Pharmacokinetics & Pharmacodynamics: Concepts and Applications –

Malcolm Rowland and Thomas N.Tozer, Wolters Kluwer, Lippincott Williams &

Wilkins Publishers.

15. Applied biopharmaceutics and Pharmacokinetics, Pharmacodynamics and Drug

metabolism for industrial scientists.

16. Modern Pharmacology, Craig CR. & Stitzel RE, Little Brown & Company.


Pharmacological and Toxicological Screening Methods – I

(MPL 103T)


This subject is designed to impart the knowledge on preclinical evaluation of drugs and

recent experimental techniques in the drug discovery and development. The subject content

helps the student to understand the maintenance of laboratory animals as per the guidelines,

basic knowledge of various in-vitro and in-vivo preclinical evaluation processes

Objectives

Upon completion of the course the student shall be able to,

• Appraise the regulations and ethical requirement for the usage of experimental

animals.

• Describe the various animals used in the drug discovery process and good laboratory

practices in maintenance and handling of experimental animals

• Describe the various newer screening methods involved in the drug discovery process

• Appreciate and correlate the preclinical data to humans

Course Outcome

CO.1: Exhibit awareness and responsiveness to the system of health care including

preclinical evaluation of drugs, ethical requirement for the usage of animal

experiments, and regulations of the experiments.

CO.2: Graduates are able to understand the process of drug discovery, in-vivo, in-vitro

experiments, and newer screening methods.

Course content Unit 1. 12 Hrs

Laboratory Animals

• Common laboratory animals: Description, handling and applications of different

species and strains of animals.

• Transgenic animals: Production, maintenance and applications Anaesthesia and

euthanasia of experimental animals.

• Maintenance and breeding of laboratory animals. CPCSEA guidelines to conduct

experiments on animals

• Good laboratory practice.

• Bioassay-Principle, scope and limitations and methods.

Unit 2. 12 Hrs.

• Preclinical screening of new substances for the pharmacological activity using in

vivo, in vitro, and other possible animal alternative models.

• General principles of preclinical screening. CNS Pharmacology: behavioural and

muscle coordination, CNS stimulants and depressants, anxiolytics, anti-psychotics,

anti-epileptics and nootropics. Drugs for neurodegenerative diseases like

Parkinsonism, Alzheimers and multiple sclerosis. Drugs acting on Autonomic

Nervous System.

Unit 3. 12 Hrs.



• Respiratory Pharmacology: anti-asthmatics, drugs for COPD and anti allergics.

Reproductive Pharmacology: Aphrodisiacs and antifertility agents Analgesics, anti-

inflammatory and antipyretic agents. Gastrointestinal drugs: anti-ulcer, anti -emetic,

anti- diarrheal and laxatives.

Unit 4. 12 Hrs.



• Cardiovascular Pharmacology: antihypertensives, antiarrythmics, antianginal,

antiatherosclerotic agents and diuretics. Drugs for metabolic disorders like anti-

diabetic, antidyslipidemic agents. Anti-cancer agents. Hepatoprotective screening

methods.

Unit 5. 12 Hrs.



• Iimmunomodulators, Immunosuppressants and immunostimulants

• General principles of immunoassay: theoretical basis and optimization of

immunoassay, heterogeneous and homogenous immunoassay systems. Immunoassay

methods evaluation; protocol outline, objectives and preparation. Immunoassay for

digoxin and insulin

• Limitations of animal experimentation and alternate animal experiments.

• Extrapolation of in vitro data to preclinical and preclinical to humans

REFERENCES

1. Biological standardization by J.H. Burn D.J. Finney and I.G. Goodwin

2. Screening methods in Pharmacology by Robert Turner. A

3. Evaluation of drugs activities by Laurence and Bachrach

4. Methods in Pharmacology by Arnold Schwartz.

5. Fundamentals of experimental Pharmacology by M.N.Ghosh

6. Pharmacological experiment on intact preparations by Churchill Livingstone

7. Drug discovery and Evaluation by Vogel H.G.

8. Experimental Pharmacology by R.K.Goyal.

9. Preclinical evaluation of new drugs by S.K. Guta

10. Handbook of Experimental Pharmacology, SK.Kulkarni

11. Practical Pharmacology and Clinical Pharmacy, SK.Kulkarni, 3rd Edition.

12. David R.Gross. Animal Models in Cardiovascular Research, 2nd Edition, Kluwer

Academic Publishers, London, UK.

13. Screening Methods in Pharmacology, Robert A.Turner.

14. Rodents for Pharmacological Experiments, Dr.Tapan Kumar chatterjee.

15. Practical Manual of Experimental and Clinical Pharmacology by Bikash Medhi

(Author), Ajay Prakash (Author)


Cellular and Molecular Pharmacology (MPL 104T)


The subject imparts a fundamental knowledge on the structure and functions of cellular

components and help to understand the interaction of these components with drugs. This

information will further help the student to apply the knowledge in drug discovery process.

Objectives

Upon completion of the course, the student shall be able to,

• Explain the receptor signal transduction processes.

• Explain the molecular pathways affected by drugs.

• Appreciate the applicability of molecular pharmacology and biomarkers in drug

discovery process.

• Demonstrate molecular biology techniques as applicable for pharmacology

Course Outcome

CO.1: Graduates will be able to take interest in research & development in all areas

pertaining to Pharmacology.

CO.2: They are able to understand receptor signal transduction processes, molecular

pathways affected by drugs.

CO.3: This information will further help the student to apply the knowledge in drug

discovery process.

Course content Unit 1. 12 Hrs

• Cell biology

• Structure and functions of cell and its organelles

• Genome organization. Gene expression and its regulation, importance of siRNA and

micro RNA, gene mapping and gene sequencing

• Cell cycles and its regulation.

• Cell death– events, regulators, intrinsic and extrinsic pathways of apoptosis.

• Necrosis and autophagy.

Unit 2. 12 Hrs

• Cell signaling

• Intercellular and intracellular signaling pathways.

• Classification of receptor family and molecular structure ligand gated ion channels;

G-protein coupled receptors, tyrosine kinase receptors and nuclear receptors.

• Secondary messengers: cyclic AMP, cyclic GMP, calcium ion, inositol 1,4,5-

trisphosphate, (IP3), NO, and diacylglycerol.

• Detailed study of following intracellular signaling pathways: cyclic AMP signaling

pathway, mitogen-activated protein kinase (MAPK) signaling, Janus kinase

(JAK)/signal transducer and activator of transcription (STAT) signaling pathway.

Unit 3. 12 Hrs

• Principles and applications of genomic and proteomic tools DNA electrophoresis,

PCR (reverse transcription and real time), Gene sequencing, micro array technique,

SDS page, ELISA and western blotting,

• Recombinant DNA technology and gene therapy

• Basic principles of recombinant DNA technology-Restriction enzymes, various types

of vectors. Applications of recombinant DNA technology.

• Gene therapy- Various types of gene transfer techniques, clinical applications and

recent advances in gene therapy.

Unit 4. 12 Hrs

• Pharmacogenomics

• Gene mapping and cloning of disease gene.

• Genetic variation and its role in health/ pharmacology Polymorphisms affecting drug

metabolism

• Genetic variation in drug transporters

• Genetic variation in G protein coupled receptors

• Applications of proteomics science: Genomics, proteomics, metabolomics,

functionomics, nutrigenomics Immunotherapeutics

• Types of immunotherapeutics, humanisation antibody therapy, Immunotherapeutics

in clinical practice

Unit 5. 12 Hrs

a) Cell culture techniques

Basic equipment used in cell culture lab. Cell culture media, various types of cell culture,

general procedure for cell cultures; isolation of cells, subculture, cryopreservation,

characterization of cells and their application.

Principles and applications of cell viability assays, glucose uptake assay, Calcium influx

assays

Principles and applications of flow cytometry

b) Biosimilars

REFERENCES:

1. The Cell, A Molecular Approach. Geoffrey M Cooper.

2. Pharmacogenomics: The Search for Individualized Therapies. Edited by J. Licinio

and M -L. Wong

3. Handbook of Cell Signalling (Second Edition) Edited by Ralph A. et.al

4. Molecular Pharmacology: From DNA to Drug Discovery. John Dickenson et.al

5. Basic Cell Culture protocols by Cheril D.Helgason and Cindy L.Miller

6. Basic Cell Culture (Practical Approach ) by J. M. Davis (Editor)

7. Animal Cell Culture: A Practical Approach by John R. Masters (Editor)

8. Current porotocols in molecular biology vol I to VI edited by Frederick M.Ausuvel

et la.


Sub code: MPL 105

Core sub 5: Pharmacological Practical – I

Practical: 12 Hrs. /Week

1. Analysis of pharmacopoeia compounds and their formulations by UV Vis

spectrophotometer

2. Simultaneous estimation of multi component containing formulations by UV

spectrophotometry

3. Experiments based on HPLC

4. Experiments based on Gas Chromatography

5. Estimation of riboflavin/quinine sulphate by fluorimetry

6. Estimation of sodium/potassium by flame photometry

Handling of laboratory animals.

1. Various routes of drug administration.

2. Techniques of blood sampling, anesthesia and euthanasia of experimental animals.

3. Functional observation battery tests (modified Irwin test)

4. Evaluation of CNS stimulant, depressant, anxiogenics and anxiolytic,

anticonvulsant activity.

5. Evaluation of analgesic, anti-inflammatory, local anesthetic, mydriatic and miotic

activity.

6. Evaluation of diuretic activity.

7. Evaluation of antiulcer activity by pylorus ligation method.

8. Oral glucose tolerance test.

9. Isolation and identification of DNA from various sources (Bacteria, Cauliflower,

onion, Goat liver).

10. Isolation of RNA from yeast

11. Estimation of proteins by Braford/Lowry’s in biological samples.

12. Estimation of RNA/DNA by UV Spectroscopy

13. Gene amplification by PCR.

14. Protein quantification Western Blotting.

15. Enzyme based in-vitro assays (MPO, AChEs, α amylase, α glucosidase).

16. Cell viability assays (MTT/Trypan blue/SRB).

17. DNA fragmentation assay by agarose gel electrophoresis.

18. DNA damage study by Comet assay.

19. Apoptosis determination by fluorescent imaging studies.

20. Pharmacokinetic studies and data analysis of drugs given by different routes of

administration using softwares

21. Enzyme inhibition and induction activity

22. Extraction of drug from various biological samples and estimation of drugs in

biological fluids using different analytical techniques (UV)

23. Extraction of drug from various biological samples and estimation of drugs in

biological fluids using different analytical techniques (HPLC)

REFERENCES

1. CPCSEA, OECD, ICH, USFDA, Schedule Y, EPA guidelines,

2. Fundamentals of experimental Pharmacology by M.N.Ghosh

3. Handbook of Experimental Pharmacology by S.K. Kulkarni.

4. Drug discovery and Evaluation by Vogel H.G.

5. Spectrometric Identification of Organic compounds - Robert M Silverstein,

6. Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler, Timothy A.

Nieman,

7. Vogel’s Text book of quantitative chemical analysis - Jeffery, Basset, Mendham,

Denney,

8. Basic Cell Culture protocols by Cheril D. Helgason and Cindy L.Mille

9. Basic Cell Culture (Practical Approach) by J. M. Davis (Editor)

10. Animal Cell Culture: A Practical Approach by John R. Masters (Editor) Practical

Manual of Experimental and Clinical Pharmacology by Bikash Medhi(Author),

Ajay Prakash (Author) Jaypee brothers’ medical publishers Pvt. Ltd

SEMESTER II

M.PHARM PHARMACOLOGY SEMESTER II

Advanced Pharmacology – II (MPL 201T)


The subject is designed to strengthen the basic knowledge in the field of pharmacology and

to impart recent advances in the drugs used for the treatment of various diseases. In

addition, this subject helps the students to understand the concepts of drug action and

mechanisms involved.

Objectives

Upon completion of the course the student shall be able to

• Discuss the pathophysiology and pharmacotherapy of certain diseases

• Explain the mechanism of drug actions at cellular and molecular level

• Understand the adverse effects, contraindications and clinical uses of drugs used in

treatment of diseases

Course Outcomes

CO.1: strengthens the knowledge of Pharmacology, Pathophysiology and

Pharmacotherapeutics.

CO.2: It makes students to understand the mechanism of the drug at molecular level,

adverse drug effect, clinical use, Contraindications, and dosage of the drug

Course content Unit 1 12 Hrs.

• Endocrine Pharmacology

• Molecular and cellular mechanism of action of hormones such as growth hormone,

• prolactin, thyroid, insulin and sex hormones

• Anti-thyroid drugs, Oral hypoglycemic agents, Oral contraceptives, Corticosteroids.

• Drugs affecting calcium regulation

Unit 2 12 Hrs.

• Chemotherapy

• Cellular and molecular mechanism of actions and resistance of antimicrobial agents

• such as ß-lactams, aminoglycosides, quinolones, Macrolide antibiotics. Antifungal,

antiviral, anti-TB drugs.

Unit 3 12Hrs.

• Chemotherapy

• Drugs used in Protozoal Infections

• Drugs used in the treatment of Helminthiasis Chemotherapy of cancer

Immunopharmacology

• Cellular and biochemical mediators of inflammation and immune response. Allergic

or hypersensitivity reactions. Pharmacotherapy of asthma and

• COPD.

• Immunosuppressants and Immunostimulants

Unit 4 12 Hrs.

• GIT Pharmacology

• Antiulcer drugs, Prokinetics, antiemetics, anti-diarrheals and drugs for constipation

and irritable bowel syndrome.

• Chronopharmacology

• Biological and circadian rhythms, applications of chronotherapy in various diseases

like cardiovascular disease, diabetes, asthma and peptic ulcer

Unit 5 12 Hrs.

• Free radicals Pharmacology

• Generation of free radicals, role of free radicals in etiopathology of various diseases

such as diabetes, neurodegenerative diseases and cancer. Protective activity of certain

important antioxidant

• Recent Advances in Treatment: Alzheimer’s disease, Parkinson’s disease, Cancer,

Diabetes mellitus

REFERENCES

1. The Pharmacological basis of therapeutics- Goodman and Gill man‘s

2. Principles of Pharmacology. The Pathophysiologic basis of drug therapy by David

E Golan et al.

3. Basic and Clinical Pharmacology by B.G -Katzung

4. Pharmacology by H.P. Rang and M.M. Dale.

5. Hand book of Clinical Pharmacokinetics by Gibaldi and Prescott.

6. Text book of Therapeutics, drug and disease management by E T. Herfindal and

Gourley.


B.C.Yu.

8. Handbook of Essential Pharmacokinetics, Pharmacodynamics and Drug

Metabolism for Industrial Scientists

9. Robbins & Cortan Pathologic Basis of Disease, 9th Ed. (Robbins

10. Pathology)

11. A Complete Textbook of Medical Pharmacology by Dr. S.K Srivastava published

by APC Avichal Publishing Company.

12. KD.Tripathi. Essentials of Medical Pharmacology

13. Principles of Pharmacology. The Pathophysiologic basis of drug Therapy by David

Golan Armen H, Tashjian Jr, Ehrin J,Armstrong, April W, Armstrong, Wolters,

Kluwer-Lippincott Williams & Wilkins Publishers


Pharmacological and Toxicological Screening Methods – II

(MPL 202T)


This subject is designed to impart the knowledge on preclinical evaluation of drugs and

recent experimental techniques in the drug discovery and development. The subject content

helps the student to understand the maintenance of laboratory animals as per the guidelines,

basic knowledge of various in-vitro and in-vivo preclinical evaluation processes

Objectives

Upon completion of the course the student shall be able to,

• Appraise the regulations and ethical requirement for the usage of experimental

animals.

• Describe the various animals used in the drug discovery process and good laboratory

practices in maintenance and handling of experimental animals

• Describe the various newer screening methods involved in the drug discovery process

• Appreciate and correlate the preclinical data to humans

Course Outcome

CO.1: Exhibit awareness and responsiveness to the system of health care including

preclinical evaluation of drugs, ethical requirement for the usage of animal

experiments, and regulations of the experiments.

CO.2: Graduates are able to understand the process of drug discovery, in-vivo, in-vitro

experiments, and newer screening methods.


Basic definition and types of toxicology (general, mechanistic, regulatory and descriptive)

Regulatory guidelines for conducting toxicity studies OECD, ICH, EPA and Schedule Y

OECD principles of Good laboratory practice (GLP) History, concept and its importance

in drug development

Unit 2 12 Hrs.

Acute, sub-acute and chronic- oral, dermal and inhalational studies as per OECD

guidelines. Acute eye irritation, skin sensitization, dermal irritation & dermal toxicity

studies. Test item characterization- importance and methods in regulatory toxicology

studies

Unit 3 12 Hrs.

• Reproductive toxicology studies, Male reproductive toxicity studies, female

reproductive studies (segment I and segment III), teratogenecity studies (segment II)

• Genotoxicity studies (Ames Test, in vitro and in vivo Micronucleus and

Chromosomal aberrations studies) In vivo carcinogenicity studies

Unit 4 12 Hrs.

IND enabling studies (IND studies)- Definition of IND, importance of IND, industry

perspective, list of studies needed for IND submission. Safety pharmacology studies-

origin, concepts and importance of safety pharmacology. Tier1- CVS, CNS and respiratory

safety pharmacology, HERG assay. Tier2- GI, renal and other studies

Unit 5 12 Hrs.

Toxicokinetics- Toxicokinetic evaluation in preclinical studies, saturation kinetics

Importance and applications of toxicokinetic studies. Alternative methods to animal

toxicity testing.

REFERENCES

14. Hand book on GLP, Quality practices for regulated non-clinical research and

development (http://www.who.int/tdr/publications/documents/glp- handbook.pdf).

15. Schedule Y Guideline: drugs and cosmetics (second amendment) rules,

16. 2005, ministry of health and family welfare (department of health) New Delhi

17. Drugs from discovery to approval by Rick NG.

18. Animal Models in Toxicology, 3rd Edition, Lower and Bryan

19. OECD test guidelines.

20. Principles of toxicology by Karen E. Stine, Thomas M. Brown.

21. Guidance for Industry M3(R2) Nonclinical Safety Studies for the Conduct of

Human Clinical Trials and Marketing Authorization for Pharmaceuticals

(http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinform

ation/guidances/ucm073246.pdf)


Principles of Drug Discovery (MPL 203T)


The subject imparts basic knowledge of drug discovery process. This information will make

the student competent in drug discovery process

Objectives


• Explain the various stages of drug discovery.

• Appreciate the importance of the role of genomics, proteomics and bioinformatics in

drug discovery

• Explain various targets for drug discovery.

• Explain various lead seeking method and lead optimization

• Appreciate the importance of the role of computer aided drug design in drug discovery

Course Outcome

CO.1: Graduates will be able to take interest in research & development in all areas

pertaining to Pharmacology.

CO.2: They are able to understand receptor signal transduction processes, molecular

pathways affected by drugs.

CO.3: This information will further help the student to apply the knowledge in drug

discovery process.


An overview of modern drug discovery process: Target identification, target validation,

lead identification and lead Optimization. Economics of drug discovery.

Target Discovery and validation-Role of Genomics, Proteomics and Bioinformatics. Role

of Nucleic acid microarrays, Protein microarrays, Antisense technologies, siRNAs,

antisense oligonucleotides, Zinc finger proteins. Role of transgenic animals in target

validation.

Unit 2 12 Hrs.

Lead Identification- combinatorial chemistry & high throughput screening, in silico lead

discovery techniques, Assay development for hit identification.

Protein structure, Levels of protein structure, Domains, motifs, and folds in protein

structure. Computational prediction of protein structure: Threading and homology

modeling methods. Application of NMR and X-ray crystallography in protein structure

prediction

Unit 3 12 Hrs.

Rational Drug Design

Traditional vs rational drug design, Methods followed in traditional drug design, High

throughput screening, Concepts of Rational Drug Design, Rational Drug Design Methods:

Structure and Pharmacophore based approaches, Virtual Screening techniques: Drug

likeness screening, Concept of pharmacophore mapping and pharmacophore based

Screening

Unit 4 12 Hrs.

Molecular docking: Rigid docking, flexible docking, manual docking; Docking based

screening. De novo drug design. Quantitative analysis of Structure Activity Relationship

History and development of QSAR, SAR versus QSAR, Physicochemical parameters,

Hansch analysis, Fee Wilson analysis and relationship between them.

Unit 5 12 Hrs.

QSAR Statistical methods – regression analysis, partial least square analysis (PLS) and

other multivariate statistical methods. 3D-QSAR approaches like COMFA and COMSIA

Prodrug design-Basic concept, Prodrugs to improve patient acceptability, Drug solubility,

Drug absorption and distribution, site specific drug delivery and sustained drug action.

Rationale of prodrug design and practical consideration of prodrug design

REFERENCES

1. MouldySioud. Target Discovery and Validation Reviews and Protocols: Volume 2

Emerging Molecular Targets and Treatment Options. 2007 Humana Press Inc.

2. Darryl León. Scott Markel In Silico Technologies in Drug Target Identification and

Validation. 2006 by Taylor and Francis Group, LLC.

3. Johanna K. DiStefano. Disease Gene Identification. Methods and Protocols.

Springer New York Dordrecht Heidelberg London.

4. Hugo Kubiny. QSAR: Hansch Analysis and Related Approaches. Methods and

Principles in Medicinal Chemistry. Publisher Wiley-VCH

5. Klaus Gubernator, Hans-Joachim Böhm. Structure-Based Ligand Design. Methods

and Principles in Medicinal Chemistry. Publisher Wiley-VCH

6. Abby L. Parrill. M. Rami Reddy. Rational Drug Design. Novel Methodology and

Practical Applications. ACS Symposium Series; American Chemical Society:

Washington, DC, 1999.

7. J. Rick Turner. New drug development design, methodology and, analysis. John

Wiley & Sons, Inc., New Jersey.


Clinical Research and Pharmacovigilance (MPL 204T)

Theory: 4 Hrs. /Week Scope:

This subject will provide a value addition and current requirement for the students in

clinical research and pharmacovigilance. It will teach the students on conceptualizing,

designing, conducting, managing and reporting of clinical trials. This subject also focuses

on global scenario of Pharmacovigilance in different methods that can be used to generate

safety data. It will teach the students in developing drug safety data in Pre-clinical, Clinical

phases of Drug development and post market surveillance.

Objectives:


• Explain the regulatory requirements for conducting clinical trial

• Demonstrate the types of clinical trial designs

• Explain the responsibilities of key players involved in clinical trials

• Execute safety monitoring, reporting and close-out activities

• Explain the principles of Pharmacovigilance

• Detect new adverse drug reactions and their assessment

• Perform the adverse drug reaction reporting systems and communication in

Pharmacovigilance

Course Outcome

CO.1: Graduates are able to demonstrate different phases of clinical trial, able to

understand regulatory requirements for clinical trial.

CO.2: Students are able to design, conduct and manage the clinical trial. They can detect

new adverse drug reactions.

CO.3: They are able to understand the principles of Pharmacovigilance.

Course content Unit 1 12 Hrs

Regulatory Perspectives of Clinical Trials:

• Origin and Principles of International Conference on Harmonization - Good Clinical

Practice (ICH-GCP) guidelines Ethical Committee: Institutional Review Board,

Ethical Guidelines for Biomedical Research and Human Participant- Schedule Y,

ICMR

• Informed Consent Process: Structure and content of an Informed Consent Process

Ethical principles governing informed consent process

Unit 2 12 Hrs

Clinical Trials: Types and Design Experimental Study- RCT and Non RCT, Observation

Study: Cohort, Case control, Cross sectional, Clinical Trial Study Team, Roles and

responsibilities of Clinical Trial Personnel: Investigator, Study Coordinator, Sponsor,

Contract Research Organization and its management

Unit 3 12 Hrs

• Clinical Trial Documentation- Guidelines to the preparation of documents,

Preparation of protocol, Investigator Brochure, Case Report Forms, Clinical Study

Report Clinical Trial Monitoring- Safety Monitoring in CT

• Adverse Drug Reactions: Definition and types. Detection and reporting methods.

Severity and seriousness assessment. Predictability and preventability assessment,

Management of adverse drug reactions; Terminologies of ADR.

Unit 4 12 Hrs

• Basic aspects, terminologies and establishment of pharmacovigilance

• History and progress of pharmacovigilance, Significance of safety monitoring,

Pharmacovigilance in India and international aspects, WHO international drug

monitoring programme, WHO and Regulatory terminologies of ADR, evaluation of

medication safety,

• Establishing pharmacovigilance centres in Hospitals, Industry and National

programmes related to pharmacovigilance. Roles and responsibilities in

Pharmacovigilance

Unit 5 12 Hrs

Methods, ADR reporting and tools used in Pharmacovigilance

International classification of diseases, International Non- proprietary names for drugs,

Passive and Active surveillance, Comparative observational studies, Targeted clinical

investigations and Vaccine safety surveillance. Spontaneous reporting system and

Reporting to regulatory authorities, Guidelines for ADRs reporting. Argus, Aris G

Pharmacovigilance, VigiFlow, Statistical methods for evaluating medication safety data

Pharmacoepidemiology, pharmacoeconomics, safety pharmacology

REFERENCES

1. Central Drugs Standard Control Organization- Good Clinical Practices, Guidelines

for Clinical Trials on Pharmaceutical Products in India. New Delhi: Ministry of

Health;2001.

2. International Conference on Harmonization of Technical requirements for

registration of Pharmaceuticals for human use. ICH Harmonized Tripartite

Guideline. Guideline for Good Clinical Practice.E6; May 1996.

3. Ethical Guidelines for Biomedical Research on Human Subjects 2000. Indian

Council of Medical Research, New Delhi.

4. Textbook of Clinical Trials edited by David Machin, Simon Day and Sylvan Green,

March 2005, John Wiley and Sons.

5. Clinical Data Management edited by R K Rondels, S A Varley, C F Webbs. Second

Edition, Jan 2000, Wiley Publications.

6. Handbook of clinical Research. Julia Lloyd and Ann Raven Ed. Churchill

Livingstone.

7. Principles of Clinical Research edited by Giovanna di Ignazio, Di Giovanna and

Haynes.


Pharmacological Practical II (MPL 205)

Practical: 12 Hrs. /Week

1. To record the DRC of agonist using suitable isolated tissues preparation.

2. To study the effects of antagonist/potentiating agents on DRC of agonist using

suitable isolated tissue preparation.

3. To determine to the strength of unknown sample by matching bioassay by using

suitable tissue preparation.

4. To determine to the strength of unknown sample by interpolation bioassay by using

suitable tissue preparation

5. To determine to the strength of unknown sample by bracketing bioassay by using

suitable tissue preparation

6. To determine to the strength of unknown sample by multiple point bioassay by using

suitable tissue preparation.

7. Estimation of PA2 values of various antagonists using suitable isolated tissue

preparations.

8. To study the effects of various drugs on isolated heart preparations

9. Recording of rat BP, heart rate and ECG.

10. Recording of rat ECG

11. Drug absorption studies by averted rat ileum preparation.

12. Acute oral toxicity studies as per OECD guidelines.

13. Acute dermal toxicity studies as per OECD guidelines.

14. Repeated dose toxicity studies- Serum biochemical, haematological, urine analysis,

functional observation tests and histological studies.

15. Drug mutagenicity study using mice bone-marrow chromosomal aberration test.

16. Protocol design for clinical trial.(3 Nos.)

17. Design of ADR monitoring protocol.

18. In-silico docking studies. (2 Nos.)

19. In-silico pharmacophore based screening.

20. In-silico QSAR studies.

21. ADR reporting

REFERENCES

1. Fundamentals of experimental Pharmacology-by M.N.Ghosh

2. Hand book of Experimental Pharmacology-S.K.Kulakarni

3. Text book of in-vitro practical Pharmacology by Ian Kitchen

4. Bioassay Techniques for Drug Development by Atta-ur-Rahman, Iqbal choudhary

and William Thomsen


B.C.Yu.

6. Handbook of Essential Pharmacokinetics, Pharmacodynamics and Drug

Metabolism for Industrial Scientists.

M. PHARM SEMESTER III

RESEARCH METHODOLOGY & BIOSTATISTICS

(MRM 301T)


This subject deals with various established methods used in pharmaceutical research.

Objectives

Upon completion of the course student shall be able to understand

Learn general research methodology and the basic concepts of biostatistics.

Understand the functions of ethics committees in medical research.

Course Outcomes

CO1 Able to carry out different parametric and non-parametric tests

CO2 Lean about the ethics committee and its function in medical research

CO3 Learn the guidelines for the experimentation on animals

CO4 prepare protocol for Animal study

Course content

Unit 1 12 Hrs

General Research Methodology:

Research, objective, requirements, practical difficulties, review of literature, study design,

types of studies, strategies to eliminate errors/bias, controls, randomization, crossover

design, placebo, blinding techniques.

Unit 2 12 Hrs

Biostatistics:

Definition, application, sample size, importance of sample size, factors influencing sample

size, dropouts, statistical tests of significance, type of significance tests, parametric

tests(students “t” test, ANOVA, Correlation coefficient, regression), non-parametric tests

(wilcoxan rank tests, analysis of variance, correlation, chi square test), null hypothesis, P

values, degree of freedom, interpretation of P values.

Unit 3 12 Hrs

Medical Research:

History, values in medical ethics, autonomy, beneficence, non- maleficence, double effect,

conflicts between autonomy and beneficence/non- maleficence, euthanasia, informed

consent, confidentiality, criticisms of orthodox medical ethics, importance of

communication, control resolution, guidelines, ethics committees, cultural concerns, truth

telling, online business practices, conflicts of interest, referral, vendor relationships,

treatment of family members, sexual relationships, fatality.

Unit 4 12 Hrs

CPCSEA guidelines for laboratory animal facility:

Goals, veterinary care, quarantine, surveillance, diagnosis, treatment and control of disease,

personal hygiene, location of animal facilities to laboratories, anaesthesia, euthanasia,

physical facilities, environment, animal husbandry, record keeping, SOPs, personnel and

training, transport of lab animals.

Unit 5 12 Hrs

Declaration of Helsinki:

History, introduction, basic principles for all medical research, and additional principles for

medical research combined with medical care.

SAURASHTRA UNIVERSITY RAJKOT · 2020. 6. 15. · Medicinal and scientific research skills,...

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